Biomarker t6A for Early Detection of Bacterial Infection in Newborns

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational, open-label cohort study will enroll newborns who require blood testing for suspected bacterial infection or routine screening at two European centers. Researchers will measure levels of the t6A biomarker and compare their diagnostic performance to standard markers like CRP, PCT, and IL-6. The goal is to see if t6A can reliably identify EOS on day one, potentially enabling faster and more accurate treatment decisions. The study is conducted at Salzburg and Wroclaw with collaboration from trauma and research institutes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Newborn infants who require blood testing for screening for bacterial infection OR treating physician suspects bacterial infection in newborn infant
* Signed informed consent form

Exclusion Criteria:

1. Refusal to participate in study or not providing written informed consent by caregivers/parents
2. Antibiotic treatment of any kind.

Where it's running

• Paracelsus Medical Private University- University Hospital Salzburg Dept. of Pediatrics and Adolescent Medicine, Division of Neonatology
  Salzburg, Austria Recruiting
• Wroclaw Medical University
  Wroclaw, Poland Not yet recruiting

Study contacts

• Study coordinator: Lorenz Stana-Hackenberg, MD
• Email: L.stana-hackenberg@salk.at
• Phone: +4357255-57757

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.